Results of the UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) trial, showed that Spiriva HandiHaler (tiotropium bromide inhalation powder), sustained improvements in lung function for up to four years as measured by FEV1 (p<0.001) versus placebo in Chronic Obstructive Pulmonary Disease (COPD) patients. It did not significantly reduce the accelerated rate of decline in lung function, as measured by FEV1, which was the primary endpoint of the study. The landmark study, published online in the New England Journal of Medicine and presented at the European Respiratory Society (ERS) Annual Congress, also reaffirmed the well-established, long-term safety profile of Spiriva.
UPLIFT, one of the largest COPD trials ever undertaken, is a four-year multicenter (470 sites), multinational (37 countries), randomized, double-blind, placebo-controlled, parallel-group prospective trial. The study included 5993 male and female COPD patients. Patients were randomized 1:1 to receive either 18 ?g tiotropium or placebo (control) once daily. In both arms, patients were allowed to use all other prescribed respiratory medications, except for inhaled anticholinergics.
"With UPLIFT, the bar was set high, as patients were allowed treatment with all other respiratory medications, except for inhaled anticholinergics," said Dr Donald Tashkin, lead investigator of the UPLIFT trial and professor at the David Geffen School of Medicine at the University of California at Los Angeles. "So the effects seen over the long term on lung function, exacerbation rates and patients' quality of life and safety are excellent news for patients and physicians."
The data also demonstrate that SPIRIVA provides important respiratory improvements in patients with moderate COPD (GOLD -Global Initiative for Chronic Obstructive Lung Disease- stage II). Forty-six percent of the patients in the UPLIFT trial were gold stage II. This is one of the largest COPD stage II patient populations ever studied over four years. The results obtained for this patient group are especially relevant as this is the stage when patients normally first seek treatment for COPD symptoms and diagnosis.
UPLIFT data suggest that SPIRIVA sustains positive effects for patients with COPD. "Importantly, the UPLIFT study highlights the well-established, long term safety profile of SPIRIVA. Almost 6,000 patients were followed for up to four years, adding to the more than 10 million patient years of market experience for SPIRIVA," commented Dr Andreas Barner, vice chairman of the board of managing directors at Boehringer Ingelheim responsible for research, development and medicine. "This is the type of meaningful data that Boehringer Ingelheim and Pfizer are committed to bringing physicians and patients dealing with COPD. We are excited about these results and look forward to physicians incorporating these findings into clinical application."
Spiriva HandiHaler is a once-daily inhaled maintenance prescription treatment for breathing problems (airway narrowing) associated with COPD. COPD includes both chronic bronchitis and emphysema.
Boehringer Ingelheim Pharmaceuticals, Inc, based in Ridgefield, CT, is the largest US subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.